Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 50 and 80 years of age
• People who have been clinically diagnosed with mild Alzheimer's disease dementia using a recognised set of diagnostic standards (NINCDS/ADRDA criteria, 2011)
• People whose most recent memory test score (called the MMSE) was between 10 and 26, taken within the last 3 months
• People whose most recent dementia rating score (called the CDR) was 1, taken within the last 3 months
• People who are in generally good physical health, with blood, urine, and heart test results within normal ranges, or meeting specific acceptable levels for liver enzymes, a muscle enzyme, kidney function, and blood sugar control (confirm specific values with trial site)
• People who — or whose caregivers — have noticed memory loss plus at least one other thinking difficulty, such as problems with language, attention, orientation, problem-solving, or daily tasks
• People whose thinking and memory difficulties have affected their ability to work or take part in social activities
• People whose condition has shown a gradual and ongoing decline from a previous level of functioning
• Women who are past menopause (more than one year without a period, not due to hormone replacement therapy) or who have had a surgical procedure making pregnancy impossible; women who could still become pregnant must have a negative pregnancy test at the screening visit, must not be breastfeeding, and must use an adequate form of birth control if sexually active; men who are sexually active must also use an adequate form of birth control
• People who have at least a basic level of education (equivalent to primary/elementary school) and are able to communicate and complete the study assessments

Who may not be able to join:

• People whose dementia is caused by something other than Alzheimer's disease
• People who have significant disease affecting the blood vessels of the brain, such as a history of stroke or bleeding in the brain that appeared to be linked to the start or worsening of their memory problems
• People with a history of cancer (other than a type of minor skin cancer called basal cell carcinoma) or who have received cancer treatment in the last 5 years
• People with uncontrolled heart problems, such as ongoing heart failure, a fast or irregular heartbeat, or uncontrolled high blood pressure
• People with significant heart disease, including a heart attack in the last two years, ongoing chest pain, or heart failure classified at a serious level (NYHA class III or IV)
• People with significant stomach or bowel problems, such as gastrointestinal bleeding in the last two years, difficulty absorbing nutrients, previous stomach removal surgery, or an active stomach ulcer
• People with uncontrolled hormonal or gland conditions, such as uncontrolled diabetes or an overactive thyroid
• People with unstable or uncontrolled major depression
• People with another neurological condition besides Alzheimer's disease, such as Parkinson's disease, epilepsy, Huntington's disease, Lewy body dementia, multiple sclerosis, stroke, or a condition present from birth affecting mental development
• People with a significant lung condition that could cause low oxygen levels in the body
• People with serious physical illnesses such as a brain tumour, significant head injury, or thyroid disease
• People with other psychiatric conditions such as schizophrenia or significant intellectual disability
• People who have made a suicide attempt or taken preparatory steps toward suicide in the past 2 years, as assessed by the investigator
• People with a score above 4 on a standard scale used to assess the likelihood of vascular causes of memory problems (Hachinski Ischemic Score)
• People with a significant history of dependence on or misuse of drugs or alcohol
• People with significant uncorrected hearing loss that the investigator considers clinically important (hearing aids are permitted)
• People who are considered ineligible for other reasons in the opinion of the investigators, including people who are unable to swallow a capsule whole

Important: Always verify eligibility with the trial site directly before applying.